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ISO 80369-5
Blood Pressure (Limb Cuff Inflation)
• Connector test protocol and validation tests with respect
to interconnectability and functionality are complete
• The standard is expected to publish by the end of 2015
ISO 80369-6
Neuraxial Devices
• Standard work is in ISO, Geneva
• Efforts to delay the implementation of CA Mandate Bill AB
1847 has passed through multiple steps and is awaiting
the Governor’s signature. A successful resolution will push
the deadline to January, 2017.
• The standard is expected to be published by the end of 2015
ISO 80369-7
Intravascular (IV) or Hypodermic
• DIS complete
• Validation testing is underway
• FDIS submission still to happen
• The standard is expected to publish in early 2016
When Will it Come into Effect?
ISO 80369-1 is published and active currently. There are
several requirements that can be followed to ensure non-
interconnectability with connector sets based on criteria
outlined within the standard. Determining the exact time the
80369 sub-standards will come into effect can be a difficult
task as they are still under development. Our team is on the
front lines in the development of these standards, allowing
us great insight to when these standards will be released.
We will be updating our website regularly to when these
changes will occur as we get more information.
How Does it Impact Me?
Compliance with the ISO 80369 standard may require major
changes on the part of medical device manufacturers. In
the next few years, if these standards are approved it could
mean new designs, new parts, new moldings and updating
or replacing millions of components. The 80369 standard
series will eventually define connector set geometries for
specific applications, meaning new connectors will be
needed to replace luers in a multitude of areas. Nordson
MEDICAL has taken a very active role in the development of
these standards to help reduce the impact of this change
on our customers.
How Can I Prepare?
While the standards have not yet been completely
established, the main precaution that medical device
manufacturers can take to help prevent any future problems
is to stay up-to-date on ISO 80369 news. Nordson
MEDICAL is one of only a few connector companies
worldwide actively participating on ISO 80369 committees.
To keep the medical device community apprised of new
developments, we have chosen to provide information in
one web location. Nordson MEDICAL has set up an online
resource to help medical device OEMs stay informed of the
changes and updates to this standard.
To read the latest updates, subscribe to alerts, and view
related resources, go to Nordson MEDICAL’s online resource
a
t i8.nordsonmedical.com.ISO 80369 STANDARDS & UPDATES
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